Pemetrexed Clonmel 25 mg/ml concentrate for solution for infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Pemetrexed

Tersedia dari:

Clonmel Healthcare Ltd

Kode ATC:

L01BA; L01BA04

INN (Nama Internasional):

Pemetrexed

Dosis:

25 milligram(s)/millilitre

Bentuk farmasi:

Concentrate for solution for infusion

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Area terapi:

Folic acid analogues; pemetrexed

Status otorisasi:

Marketed

Tanggal Otorisasi:

2016-02-05

Selebaran informasi

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED CLONMEL 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Pemetrexed Clonmel is and what it is used for
2. What you need to know before you use Pemetrexed Clonmel
3. How to use Pemetrexed Clonmel
4. Possible side effects
5. How to store Pemetrexed Clonmel
6. Contents of the pack and other information
1. WHAT PEMETREXED CLONMEL IS AND WHAT IT IS USED FOR
Pemetrexed Clonmel is a medicine used in the treatment of cancer.
Pemetrexed Clonmel is given in combination with cisplatin, another
anti-cancer medicine, as treatment
for malignant pleural mesothelioma, a form of cancer that affects the
lining of the lung, to patients who
have not received prior chemotherapy.
Pemetrexed Clonmel is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Product name can be prescribed to you if you have lung cancer at an
advanced stage if your disease has
responded to treatment or it remains largely unchanged after initial
chemotherapy.
Pemetrexed Clonmel is also a treatment for patients with an advanced
stage of lung cancer whose disease
has progressed after other initial chemotherapy has been used.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PEMETREXED CLONMEL
DO NOT USE PEMETREXED CLONMEL
•
if you are allergic to pemetrexed or any of the other ingredients of
this medicine (listed in section 6)
•
if you are breast-feeding; you must discontinue breast-feeding during
treatment with Pemetrexed
Clonmel
•
if you have recently received or are about to receive a vaccin

Karakteristik produk

Health Products Regulatory Authority
23 January 2024
CRN00F2LL
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Clonmel 25 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml concentrate contains 25 mg pemetrexed (as 30.21 mg pemetrexed
disodium 2.5-hydrate)
Each 4 ml vial contains 100 mg of pemetrexed (as 120.83 mg pemetrexed
disodium 2.5-hydrate).
Each 20 ml vial contains 500 mg of pemetrexed (as 604.13 mg pemetrexed
disodium 2.5-hydrate).
Each 40 ml vial contains 1000 mg of pemetrexed (as 1 208.26 mg
pemetrexed disodium 2.5-hydrate).
Excipient with known effect:
1 ml concentrate contains approximately 3.18 mg sodium
Each 4 ml vial contains approximately 12.72 mg sodium.
Each 20 ml vial contains approximately 63.60 mg sodium.
Each 40 ml vial contains approximately 127.20 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to either light yellow or light green-yellow
solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Clonmel in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Clonmel in combination with cisplatin is indicated for the
first line treatment of patients with locally advanced or
metastatic non-small cell lung cancer other than predominantly
squamous cell histology (see section 5.1).
Pemetrexed Clonmel is indicated as monotherapy for the maintenance
treatment of locally advanced or metastatic non-small
cell lung cancer other than predominantly squamous cell histology in
patients whose disease has not progressed immediately
following platinum-based chemotherapy (see section 5.1).
Pemetrexed Clonmel is indicated as monotherapy for the second line
treatment of patients with locally advanced or metastatic
non-small cell lung cancer other than predominantly s